SOR/2017-12: Regulations Amending Certain Regulations Made Under the Controlled Drugs and Substances Act
REGISTRATION OF FEDERAL REGULATION - VIA OIC DATABASE, PRIOR TO PART II OF THE GAZETTE
February 3, 2017
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations or the Order.) Issues The Controlled Drugs and Substances Act (CDSA) and its regulations provide a framework for the control of substances that can alter mental processes and that may cause harm to health or to society when diverted to an illicit market or used inappropriately. Its purpose is to protect public hea... (Click for more)
Published on February 10, 2017
SOR/2017-12: Regulations Amending Certain Regulations Made Under the Controlled Drugs and Substances Act
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations or the Order.) Issues The Controlled Drugs and Substances Act (CDSA) and its regulations provide a framework for the control of substances that can alter mental processes and that may cause harm to health or to society when diverted to an illicit market or used inappropriately. Its purpose is to protect public health and maintain public safety by prohibiting certain activities associated with harmful substances, while allowing access to those substances for legitimate medical, scientific and industrial purposes. Substances that are not psychoactive, or that cannot readily be converted to psychoactive substances, are generally not controlled under the CDSA. However, Health Canada has determined that several substances that do not pose risks to public health and safety are currently controlled under the CDSA. Barbituric acid Barbituric acid, the parent compound of barbiturate drugs, (see footnote 4) was regulated in the early 1960s at the same time as other barbiturate drugs. However, it does not possess any psychoactive properties. (see footnote 5) Health Canada has determined that the likelihood of its illicit use is very low. This is supported by domestic and international data. The International Narcotics Control Board has not received any government reports of illicit manufacture of barbiturates using barbituric acid or any instances of the diversion of barbiturates from international trade over the past several years. Barbituric acid has not been identified in any drug seizure exhibits analyzed by Health Canada’s Drug Analysis Service going back at least 14 years. Barbituric acid has a variety of legitimate industrial uses including testing for levels of sorbic acid (a food preservative) in alcohol, testing of cyanide levels in water, and in the manufacture of paint. The controlled status of barbituric acid makes it harder and more costly for stakeholders to access it in a timely manner. 1,3-dimethylbarbituric acid 1,3-dimethylbarbituric acid was regulated at the same time as other barbiturate drugs, as it is captured via the larger heading of “barbiturates, their salts and derivatives” under Schedule IV to the CDSA. Similar to barbituric acid, it lacks psychoactive effects. (see footnote 6) Health Canada has found no evidence that 1,3-dimethylbarbituric acid is being used for anything other than legitimate purposes in Canada or internationally. A review of the scientific literature as well as a web search of drug forums and other sites related to drug use, conducted in the spring of 2016, did not uncover any information related to recreational use of or addiction to this substance. 1,3-dimethylbarbituric acid is used as a colour-forming reagent when testing for cyanide in environmental samples such as water. This type of testing is conducted by environmental testing laboratories in order to fulfill federal, provincial and municipal regulations. These laboratories have outlined a number of barriers as a result of the control status of this substance including: long wait times, difficulty in increasing stock amounts quickly, and problems in obtaining a secure supply. Clozapine-N-oxide (CNO) CNO is a major metabolite (derivative) of clozapine. Clozapine is an antipsychotic medication used in the treatment of schizophrenia and is excluded from the CDSA and the Benzodiazepines and Other Targeted Substance Regulations (BOTSR). Since CNO is not specifically excluded in the CDSA along with its parent substance, clozapine, it is controlled under the Act. Health Canada has found no evidence of CNO being used for anything other than legitimate purposes in Canada or internationally. A review of the scientific literature as well as a web search of drug forums and other sites related to drug use, conducted in the spring of 2016, did not reveal any information related to recreational use of or addiction to CNO. CNO is used extensively for legitimate scientific research, particularly in the context of brain research using engineered receptors that allow for precise experimental manipulation of neuronal activity. CNO is used in research on neurological and psychiatric diseases or disorders including Alzheimer’s, Parkinson’s diseases and autism. The control status of CNO has meant not only compliance and administrative costs for researchers, but also delays in accessing CNO, difficulty in increasing stock amounts quickly and problems in obtaining a secure supply. Salts of nalmefene, naloxone and naltrexone, and naloxegol, methylnaltrexone and their salts Naloxone, naltrexone and nalmefene are opioid antagonists and are not psychoactive. They are specifically listed as exclusions under item 1 of Schedule I to the CDSA and in the schedule to the Narcotic Control Regulations (NCR). These substances are used clinically for the reversal of opioid overdose and the treatment of opioid addiction. In contrast, their salts, used for the same legitimate uses, are controlled under the CDSA by virtue of the fact that the exclusions for the above-noted substances make no reference to their salts. Certain derivatives of naltrexone (namely methylnaltrexone) and of naloxone (namely naloxegol) are used clinically for the treatment of opioid-induced constipation in adults with chronic non-cancer pain. However, as noted above with the salts of naloxone, naltrexone and nalmafene, both methylnatrexone and naloxegol are controlled because the listing excluding their parent substance does not make any reference to them. Clinical studies of naloxegol and methylnaltrexone suggest that these substances have very limited ability to cross the blood-brain barrier. Moreover, neither substance is associated with adverse events suggestive of a potential for addiction, or of withdrawal effects associated with cessation of these substances. As a result, Health Canada’s conclusions are that neither substance is likely to have any dependence or addiction liability; thus these substances and their salts do not need to be subject to the controls set out in the CDSA and its regulations. The controlled status of these substances creates barriers for quick access and added costs for businesses using these substances to create therapeutic products. Salts of 14 substances currently excluded from the CDSA There are 14 substances (apomorphine, cyprenorphine, narcotine, papaverine, carbamethidine, (see footnote 7) oxpheneridine, ethoheptazine, metethoheptazine, metheptazine, dextromethorphan, dextrorphan, levallorphan, levargorphan and cyclazocine) that are excluded from the application of the CDSA. However, their salt forms are not captured within the exclusion. These salts do not have psychoactive properties, do not pose a threat to public health or safety, and are contained in a variety of products currently sold in Canada. The controlled status of these salts creates unintentional non-compliance with the CDSA because manufacturers, retailers and consumers unknowingly have controlled substances in their possession. (see footnote 8) In contrast to the above-mentioned substances that should not be controlled under the CDSA, Health Canada has identified substances that must remain controlled under the CDSA, but for which there are issues with respect to their placement within existing schedules. Salts of butorphanol and nalbuphine Butorphanol and nalbuphine are specifically controlled under Schedule IV to the CDSA and the schedule to Part G of the Food and Drug Regulations (FDR). These two substances are also morphinans, a class of substances included in Schedule I of the CDSA and in the schedule to the NCR. In order to clarify that these substances should be controlled under Schedule IV of the CDSA and the schedule to Part G of the FDR, they were excluded from Schedule I to the CDSA and the schedule to the NCR. However, this exclusion did not include their salts. Therefore the salts of butorphanol and nalbuphine are currently captured under two schedules of the CDSA, in the schedule to Part G of the FDR and in the schedule to the NCR. This lack of clarity can cause confusion with respect to penalties associated with these salts, since penalties associated with a Schedule I and IV substance differ substantially. Catha edulis Forsk, cathine and cathinone Catha edulis Forsk is a plant whose leaves and fresh shoots are referred to as khat. The principle active ingredients in khat are cathinone and cathine, which are central nervous system stimulants related to amphetamine, and which have pharmacological effects that are similar to (but less potent than) amphetamine. Catha edulis Forsk, its preparations, derivatives, alkaloids and salts (including cathine) are listed under item 19 of Schedule IV to the CDSA, and cathinone is listed as item 19 of Schedule III to the CDSA. However, these substances are not listed in the schedules to any of the regulations made under the CDSA. As a result, there exists no regulatory mechanism to allow access to these substances for legitimate purposes (such as research). As a result, the only way that stakeholders can access these substances is through an exemption under the CDSA, which sometimes involves long wait times when these substances are imported into Canada. Background Health Canada’s review of several of these substances was triggered by concerns expressed by stakeholders regarding access and use of these substances for legitimate medical, scientific and industrial purposes. These stakeholders cited numerous challenges caused by the control status of these substances including long wait times to obtain exemptions; difficulties experienced when trying to increase stock amounts or switch suppliers quickly; problems in obtaining a secure supply; and high costs to adhere to security standards for controlled substances. In order to temporarily address these challenges, two class exemptions were issued by Health Canada in 2015. The first was issued on May 23, 2015, exempting barbituric acid and its salts, naloxegol and its salts, methylnaltrexone and its salts, as well as the salts of nalmefene, naloxone and naltrexone. A second class exemption was issued on July 25, 2015, exempting the salts of 14 substances listed above. Both these exemptions were renewed in 2016 for another year. More recently, stakeholders have cited similar challenges around access and use of 1,3-dimethylbarbituric acid and CNO. These challenges are addressed through the schedule amendments outlined below. Objective The objectives of these amendments are the following: Exclude the following substances and their salts from the application of the CDSA: barbituric acid, 1,3-dimethylbarbituric acid, CNO, naloxegol and methylnaltrexone; Exclude the salts of naloxone, naltrexone and nalmefene and the salts of the following 14 substances: apomorphine, cyprenorphine, narcotine, papaverine, carperidine, oxpheneridine, ethoheptazine, metethoheptazine, metheptazine, dextromethorphan, dextrorphan, levallorphan, levargorphan and cyclazocine; Extend the scope of the exclusions for butorphanol and nalbuphine to include their salts, clarifying that these salts are controlled under Schedule IV and Part G of the FDR only; and Provide a regulatory mechanism to facilitate access to Catha edulis Forsk, cathine and cathinone for research purposes, by adding these substances to the schedule to Part J of the FDR. Description Barbituric acid and 1,3-dimethylbarbituric acid and their salts are excluded from the application of the CDSA through the removal of barbituric acid in subitem 1(6) of Schedule IV to the CDSA and explicitly listing these substances in a new “but not including” list under item 1 of Schedule IV. Similar amendments have been made to the schedule to Part G of the FDR. CNO and its salts are excluded by adding them to the “but not including” list as subitem 18(35) in Schedule IV to the CDSA and subitem 1(38) in Part 1 to Schedule 1 of the BOTSR. The salts of the 14 substances (apomorphine, cyprenorphine, narcotine, papaverine, carperidine, (see footnote 9) oxpheneridine, ethoheptazine, metethoheptazine, metheptazine, dextromethorphan, dextrorphan, levallorphan, levargorphan and cyclazocine), as well as the salts of butorphanol and nalbuphine, are added to the exclusion of their parent substance under Schedule I to the CDSA and the schedule to the NCR. The salts of nalmefene, naloxone and naltrexone are excluded by adding “and its salts” to the schedule entries for these three substances under the existing “but not including” list under item 1, Schedule I to the CDSA. Naloxegol and its salts and methylnaltrexone and its salts are added to this “but not including” list. Similar amendments have also been made to the schedule to the NCR. Amendments have also been made to the schedule to Part J of the FDR to include Catha edulis Forsk, its preparations, derivatives, alkaloids and salts including cathine and cathinone. As a result, persons intending to conduct certain activities (e.g. selling, importing or exporting) with these substances can now apply for a licence to obtain authorization to conduct activities under Part J of the FDR, subject to certain exceptions. Researchers affiliated with institutions engaged in research on drugs, and who intend to use these substances for research purposes, can now (depending on their circumstances) obtain an authorization from Health Canada under Part J of the FDR, become a licensed dealer under Part J of the FDR, or obtain an exemption under the CDSA, to obtain, possess and use these substances. “One-for-One” Rule These amendments will result in administrative savings for nine businesses dealing with either 1,3-dimethylbarbituric acid or CNO. Out of these nine businesses, six were using 1,3-dimethylbarbituric acid under exemptions granted by the Minister of Health so they will no longer have to incur the administrative costs for preparing and submitting applications for exemption requests (and any exemption amendments that are needed). It is estimated that four hours on average are devoted to filling out and acquiring submission approval for one exemption application package before submitting it to Health Canada for processing and that one hour is needed for any subsequent amendments. This time and associated resources can now be redirected for use in business operations. Furthermore, the nine businesses, including three that are already licensed dealers and had either CNO or 1,3-dimethylbarbituric acid on their licence, will now have their administrative burden eliminated with respect to preparing import/export permit (3/4 of an hour) and record keeping associated with these substances (3 hours annually). The annualized administrative cost savings (constant 2012 dollars) for these businesses are estimated to be approximately $2,270 or $252 per business. Since the amendments impact administrative burden, the “One-for-One” Rule applies. Because the amendments will result in administrative savings, these amendments are considered an “OUT” under the rule and the administrative credits will be banked towards offsetting increase in administrative burden to stakeholders in the future. Small business lens Since there are no costs associated to small businesses in this scheduling amendment, the small business lens does not apply. Consultation On May 23, 2015, Health Canada published a Notice to Interested Parties (NTIP) in the Canada Gazette, Part I (CGI), to notify stakeholders and the general public regarding proposed regulatory amendments with respect to barbituric acid, naloxegol, methylnaltrexone and their salts, the salts of nalmefene, naloxone and naltrexone and Catha edulis Forsk, cathine and cathinone (http://www.gazette.gc.ca/rp-pr/p1/2015/2015-05-23/html/notice-avis-eng.php#nb3). Six comments were received — three expressed support and three were neutral. A World Trade Organization Technical Barriers to Trade notification (WTO notification) was also published at the same time; no comments were received. In addition to feedback on the NTIP, stakeholders have also urged Health Canada, over several years, to conduct a regulatory review and implement changes to the CDSA with respect to these substances. A second NTIP was published on July 25, 2015, in CGI regarding the exclusion of the salts of 14 substances currently excluded from the CDSA (http://www.gazette.gc.ca/rp-pr/p1/2015/2015-07-25/html/notice-avis-eng.php#nc3). Three comments were received — two were neutral, and one indicated a concern based on an incorrect understanding of the proposed amendments. A WTO notification was also published; however, no comments were received. This NTIP did not mention the salts of butorphanol and nalbuphine because these salts remain controlled under the CDSA and the changes are simply clarifying that the salts of these two substances are captured under Schedule IV only and not Schedule I. It is worth noting that Health Canada has received numerous letters from industry representatives and researchers outlining concerns with the current controlled status of 1,3-dimethylbarbituric acid and CNO and indicating strong support for their exclusion from the schedules to the CDSA. Not only did Health Canada hear from several individual laboratories that require 1,3-dimethylbarbituric acid for environmental testing, but also from an association representing numerous laboratory facilities across Canada, which underscored the importance of this issue to its member laboratories. Stakeholders affected by the control status of CNO include researchers at various universities across Canada working in psychology, psychiatry, neuroscience, veterinary care and animal care and ethics. More than a dozen stakeholders have expressed concern with respect to the control status of this substance. As a result, Health Canada expects high support for these amendments. Rationale These regulatory amendments ensure that substances that are not psychoactive and not harmful to the public are not subject to undue controls under the CDSA. These regulatory amendments also ensure a regular mechanism to access three controlled substances (Catha edulis Forsk, cathinone and cathine) without the need for an exemption under the CDSA. Benefits Information available to Health Canada for 2015 indicates that there are 40 stakeholders (businesses, laboratories and research institutions) dealing with one or more of the substances discussed above (with the exclusion of cathine, cathinone and Catha edulis Forsk). By removing the substances from the schedules to the CDSA and its regulations, the amendments result in benefits to these stakeholders. Of the stakeholders identified, 21 of them (19 for barbituric acid, one for methylnaltrexone and one for naloxegol), including 7 licenced dealers, are conducting activities with barbituric acid, methylnaltrexone and naloxegol under two class exemptions first granted by the Minister of Health in 2015. As per these class exemptions, stakeholders that previously held licences or exemptions for these substances no longer need to renew their licences, apply for an authorization or apply for an exemption and incur the associated costs to conduct activities with these substances. Hence, these class exemptions provide significant savings for these stakeholders through the elimination of both compliance and administrative costs. Although these class exemptions need to be renewed by Health Canada on an annual basis, they were put in place as a temporary measure only until the regulatory amendments were finalized. Thus, while the regulatory amendments do not result specifically in a further reduction of cost to these stakeholders (since they are currently operating under a class exemption), the removal of the substances from the schedules provides these stakeholders with long-term certainty with respect to the uncontrolled status of the substances. Of the remaining 19 stakeholders (8 businesses dealing with 1,3-dimethylbarbituric acid, and one business and 10 researchers dealing with CNO), 16 of them requested and were granted an exemption and the 3 remaining were already licensed dealers who had one of these substances added to their licence. As a result of the amendments, these 16 exemptees no longer have to incur costs for preparing and submitting applications for exemption requests and related compliance costs. In addition, 3 licensed dealers now have their administrative burden eliminated with respect to import/export permit and record keeping associated with these substances. Although there are no fees associated with applying for an exemption, these stakeholders are no longer required to meet the Directive on Physical Security Requirements for Controlled Substances including ongoing security monitoring. They will also no longer need to pay for shipping fees to have Health Canada send import permits to international suppliers or ship the controlled substance from the Health Canada licensed dealer to their offices. These compliance savings are estimated over a 10-year period, totalling approximately $108,920 in present value term. These stakeholders also have their administrative burden eliminated as they no longer need to apply for an exemption (3 hours per application), conduct recording keeping (3 hours annually), apply to Health Canada to import on their behalf (3/4 hour per application) and make any amendments that are needed to their exemption (one hour). Thus, the total administrative savings is estimated over a 10-year period and is approximately $44,520 in present value terms. Unquantified benefits also exist for stakeholders. For example, exemptees using 1,3-dimethylbarbituric acid and CNO will no longer be subject to limits on the quantity of controlled substances that they possess, or need to re-apply for an exemption if they would like to change their approved supplier to a new one. Laboratories currently using 1,3-dimethylbarbituric acid for their testing have outlined negative financial implications related to the controlled status of this product over and beyond administrative or compliance costs. They include clients switching to competitors in other countries who can provide immediate testing services, and missed revenue opportunities due to an inability to take on additional short-term testing due to inadequate supplies on hand. Although the positive ramifications related to the elimination of these issues cannot be quantified, it is nevertheless reasonable to assume that they will provide companies with financial savings. Researchers currently working with CNO have indicated negative implications related to the controlled status of CNO. These include delays in starting or completing research projects, loss of research grants because of an inability to access CNO in a timely manner, missed opportunities to collaborate with colleagues on short-term projects due to inadequate supplies on hand. Even though these issues cannot be quantified, it is logical to presume that their elimination will benefit the scientific community. Total compliance and administrative savings estimated for stakeholders over a 10-year period are approximately $153,440 in present value terms. As a result of the regulatory amendments, Health Canada will also incur savings as the Department no longer needs to process exemption applications. In an average year, Health Canada issues close to 20 exemptions for 1,3-dimethylbarbituric acid and CNO. The workload associated with exemption processing and issuance is based on the complexity of each application. More complex exemptions may take up to a full workday to complete. Total savings estimated over a 10-year period for exemption processing are approximately $29,550 in present value terms. Importation of substances by individuals possessing an exemption under the CDSA must also be done by Health Canada on behalf of the exempted individual. The workload associated with the issuance of an import permit on behalf of an exemptee is approximately one full workday for each individual permit. In 2015, Health Canada processed 27 import permits for 1,3-dimethylbarbituric acid, CNO, cathine and cathinone combined. Thus, the total savings estimated over a 10-year period for import permit processing are approximately $65,930 in present value terms. Health Canada also pays the importation taxes (duties) associated with these importations. These duties will no longer be disbursed by Health Canada, resulting in savings on duties estimated over a 10-year period of approximately $14,830 in present value. The total savings estimated for the government over a 10-year period are approximately $110,310 in present value terms. Total compliance and administrative savings estimated for stakeholders and government over a 10-year period are approximately $263,750 in present value terms. Costs These amendments will result in compliance costs for three businesses and one institution in one area only. This is with respect to importation duties for cathinone and cathine. (see footnote 10) These regulatory changes enable stakeholders to access cathinone and cathine through Part J of the FDR and to import these substances through a licensed dealer who will charge for import duties (whereas previously these substances were imported through Health Canada on behalf of an exemptee). Thus, import duties, which were paid by Health Canada, will now need to be paid by the stakeholder. In 2015, Health Canada processed five import permits for cathine and cathinone combined. Health Canada is assuming similar number of imports would be made by stakeholders in the following years. Thus, the cost to stakeholders estimated over a 10-year period is approximately $8,250 in present value terms. Total net savings (taking into account costs of $8,250 for three businesses) estimated for stakeholders and governments over a 10-year period are approximately $255,500 in present value terms. Since these amendments either exclude substances from the CDSA or make slight modifications to the status of substances already controlled under the CDSA, no additional costs are expected to be incurred by the government. Implementation, enforcement and service standards As part of the implementation of the amendments, Health Canada has notified stakeholders of the changes to Schedules I, III and IV to the CDSA and to the schedules to Part G and J of the FDR, Part 1 to Schedule 1 of the BOTSR as well as the schedule of the NCR. Information is also provided on Health Canada’s website. These regulatory amendments come into force on the date of their publication in the Canada Gazette, Part II. There are no additional service standards associated with these regulations other than those that already exist for issuing licences and permits under the CDSA. Contact Denis Arsenault Healthy Environments and Consumer Safety Branch Health Canada Main Stats Building 150 Tunney’s Pasture Driveway Ottawa, Ontario K1A 0K9 Email: [email protected] Footnote a S.C. 2015, c. 22, s. 4(1) Footnote b S.C. 1996, c. 19 Footnote 1 C.R.C., c. 870 Footnote 2 C.R.C., c. 1041 Footnote 3 SOR/2000-217; SOR/2003-38, s. 1 Footnote 4 Barbiturate drugs are a group of central nervous system depressants which produce effects ranging from mild sedation to general anaesthesia and are used therapeutically as anaesthetics, anticonvulsants, anxiolytics, hypnotics and sedatives. Footnote 5 According to scientific literature, in order for any barbiturate to be psychoactive, it should have a substitution at the C-5 position of its chemical structure. Barbituric acid is missing this substitution. Footnote 6 Although C-5 substituted barbiturates can be synthesized from 1,3-dimethylbarbituric acid (similar to barbituric acid), barbiturates are most commonly synthesized using easier and cheaper methods. Footnote 7 The proper name of this substance is not “carbamethidine” but “carperidine.” This correction has been added to both the CDSA and its regulations. Footnote 8 This issue was temporarily addressed with the issuance of a class exemption on July 25, 2015. Footnote 9 The erroneous entry “carbamethidine” has been replaced by “carperidine” in the CDSA and its regulations. Footnote 10 As the control status of these substances is not changing and these businesses already needed to meet the requirements of the Directive on Physical Security Requirements for Controlled Substances to access these substances in the past, they will not incur any additional expenses for security.
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